Kornimate/medical-research-clean huggingface dataset:
decompression vs. fusion for stable degenerative spondylolisthesis

Conditions: Spinal Stenosis; Spondylolisthesis

Summary: the purpose of this study is to assess the feasibility of a full-scale multicenter randomized, controlled trial comparing the effectiveness of two surgical treatments for a condition associated with lumbar spinal stenosis called degenerative lumbar spondylolisthesis. both treatments are currently used, but individual surgeons use different selection criteria for each treatment and use the procedures at different rates. the two procedures are decompression with fusion (the most common surgical procedure for spondylolisthesis) and midline-sparing decompression alone (which is also a standard treatment, but is not as widely used for treating spondylolisthesis). the investigators plan to collect the evidence on the following: 1. the feasibility of the trial protocol, and 2. preliminary data on the effectiveness of each treatment.


Eligibility criteria:
inclusion criteria: * patients deemed to be surgical candidates with focal (1-2 level) lumbar spinal stenosis (lss) and associated stable degenerative spondylolisthesis with the following characteristics: 1. a clinical history of back, buttock and leg pain with walking or standing that is improved when lying, sitting or bending forward 2. a clinical history of leg symptoms that are greater than or equal to back symptoms with walking or standing, and 3. greater than 6 months of symptoms with failed conservative care * aged 50 or over * sufficient fluency in english or french to provide informed consent and complete questionnaires with or without the need of an interpreter exclusion criteria: * greater than 25% listhesis or spinal instability as demonstrated by motion (\>5mm of translation) on flexion extension radiographs or non-loaded (mri/ct or supine x-rays) to loaded imaging (standing radiograph) * presence of kyphosis (\>0 degrees at the affected level or globally), degenerative scoliosis (\>10 degree using the cobb method) with rotatory or lateral listhesis on preoperative x-rays * clinical history of osteoporotic fracture or chronic oral steroid use * previous posterior lumbar spinal surgery (excluding prior microdiscectomy) * patients who have evidence of neurological disorders that affect physical function (e.g. peripheral neuropathy), neuromuscular disorders (e.g. multiple sclerosis, parkinson's etc.) or systemic illness (e.g. inflammatory arthritis) that affects physical function

Keywords: pilot projects feasibility studies intervention studies orthopedics orthopedic procedures neurosurgical procedures neurosurgery spine spinal fusion spondylodesis spondylosyndesis laminectomy foraminotomy decompression, surgical low back pain quality of life
hipace high frequency low energy pacing to terminate fast ventricular arrythmias

Conditions: Arrhythmias

Summary: people that have survived, or are at high risk of a lifethreatening ventricular arrhythmia are routinely offered a defibrillator (icd). an icd is an implanted device which can recognise a ventricular arrhythmia and then try to treat it, either by rapidly pacing the heart or by shocking the heart. currently, very fast ventricular arrhythmias, known as vf, can only be treated with a shock. patients find shocks painful and this study is intended to find out whether it is possible to pace the heart at very high rates during vf. it is hoped that if this is possible, further research could lead to effective treatment of vf with pacing rather than shocks, and therefore better outcomes for patients.


Eligibility criteria:
inclusion criteria: * patient is older than 18 years of age; any patient with a medtronic cardiac implantable defibrillator undergoing defibrillation testing; no contra indication to defibrillation testing patient is able to give informed consent. exclusion criteria: * patient is younger than 18 years; patient is not able to give informed consent or is unwilling to participate in the study; patient has a contraindication to defibrillation testing
dexmedetomidine improves the surgical field and postoperative recovery of nasal endoscopic surgery

Conditions: Dexmedetomidine; Bleeding; Surgical Field

Summary: studies showed dexmedetomidine (dex) could improve surgical field, but the effect for functional nasal endoscopic surgery (fess) was unclear. the investigators explored iv administration of a single loading dose dex (0.5μg/kg) for fess, and iv administration of midazolam (0.05mg/kg) as a control with comparision of surgical field, haemodynamics, ventilation parameters and recovery.

the participants received an induction of anesthesia with propofol 2-3 mg/kg, sufentanyl 0.2 μg/kg, and rocuronium 0.6 mg/kg, and then insertion of a flexible laryngeal mask airway was conducted using the index finger insertion technique by anesthesia providers with a minimum of four years endotracheal intubation experience. mechanical ventilation parameters were as follows: pressure-controlled ventilation mode, ventilation pressure: 12, respiratory rate: 12, oxygen concentration: 50%. the maintenance of general anesthesia was performed with sevoflurane at minimum alveolar concentration of 1.3. after induction, a single loading dose dex (0.5μg/kg) was iv infusion within 10 minutes, or iv administration of midazolam (0.05mg/kg). heart rate, blood pressure, tidal volume, ventilation pressure and etco2 after insertion of a lma, 10 minutes, 20 minutes, 30 minutes after drug infusion and transferred to pacu, besides heart rate and blood pressure were recorded before and after induction. surgical field was evaluated at the time of 10 minutes and 20 minutes after drug infusion. blood gas analysis was performed just transferred to pacu and before transferred to ward.

Eligibility criteria:
inclusion criteria: * 120 participants who diagnosed with nasosinusitis * the participants need undergo functional nasal endoscopic surgery * the participants signed the informed consent exclusion criteria: * the participants were excluded with any diseases about respiration, circulation, liver and kidney * the participants were rejected of the consent
prospective validation of carpet prognostic model for septic shock after allo-hsct

Conditions: Stem Cell Transplant Complications

Summary: validation of carpet prognostic model for septic shock after allo-hsct: a multicenter, prospective, and cohort study

a clinical prognostic model named carpet model for septic shock after allo-hsct has been developed and internally retrospectively validated. a multicenter, prospective cohort study is planned to validate this clinical prediction model again. the equation of the prediction model for 28-day mortality was as follows: probability(28-day mortality)=(exp⁡(y))/(1+exp⁡(y)) where y=2.343+1.328\* time of septic shock- 0.085\* albumin + 0.016 \* bilirubin-0.003\*pao2/fio2 +0.127\*lactate- 0.011 \* glomerular filtration rate

Eligibility criteria:
inclusion criteria: * age \>18 years * underwent allo-hsct * diagnosed with septic shock exclusion criteria: * experienced septic shock before enrollment * relapsed or progressed after hsct

Keywords: septic shock prognostic model allogeneic hematopoietic stem cell transplant
addressing mental health of cancer patients and caregivers using a mobile app suite

Conditions: Mental Health Wellness 1; Depression; Anxiety

Summary: a cancer diagnosis affects not only patients but also their caregivers. the purpose of this study is to test the feasibility of using a mobile app suite, intellicare, to improve the mental health of cancer patients and caregivers.

cancer patients and/or their caregivers will receive access to the mobile app suite, intellicare, as well as phone coaching that will focus on how to use the apps. intllicare is composed of separate apps that each target a specific aspect of mental health (e.g., reducing worry). the apps are interactive and designed for users to engage in short time bursts (e.g., less than a minute). intellicare was originally designed to be paired with phone coaching that focuses on how to use the apps and overcome barriers to usage.

Eligibility criteria:
inclusion criteria: * willingness and ability to comply with scheduled visits and study procedures. * caregiver/support person of patient undergoing treatment for cancer in the breast care clinic or patient undergoing treatment for cancer in the breast care clinic * owns a smart phone or they are willing to carry one during the study if one is provided. exclusion criteria: * under 18 years old * non-english speaker
a study of the effects of amprenavir, a protease inhibitor, on carbohydrate and fat metabolism in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to evaluate the effects of a 3-drug anti-hiv regimen, amprenavir (apv) plus abacavir (abc) plus lamivudine (3tc), on the way carbohydrates (sugars) and fats are metabolized (processed by the body) in hiv-infected patients who have received little or no previous anti-hiv drug therapy.

this single-site study uses an open-label, single-arm design to evaluate the effects of apv, a protease inhibitor (pi), plus concurrent nucleoside reverse transcriptase inhibitors (nrtis) abc and 3tc on carbohydrate and lipid metabolism in non-diabetic, hiv-1 infected patients initiating antiretroviral therapy. treatment duration is 24 weeks, and patients serve as their own controls. the combination therapy is evaluated for safety, tolerability, efficacy, and effects on body composition. the proportion of patients who attain plasma hiv rna below the lower limit of quantitation of the roche amplicor (less than 400 copies/ml) and ultrasensitive (less than 50 copies/ml) is measured at 24 weeks after starting therapy with apv plus abc plus 3tc.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-positive. * are at least 18 years old. * have very little or no anti-hiv drug experience (see below for details) and have never taken abc. * have a cd4 count greater than or equal to 200 cells/mm3 within 30 days prior to study entry. * have a viral load (level of hiv in the blood) greater than 500 copies/ml within 30 days prior to study entry. * agree to use effective methods of birth control during the study. exclusion criteria patients will not be eligible for this study if they: * have taken both 3tc and stavudine (d4t). * have taken a protease inhibitor (pi) or nonnucleoside reverse transcriptase inhibitor (nnrti) for more than 7 days. * have taken a pi within 60 days of study entry. * have a history of diabetes. * have a history of untreated gonad or thyroid disorder. * have a stomach or intestinal disorder which may affect the way the body absorbs the study drugs, or which may make them unable to take medications by mouth. * have received chemotherapy or radiation within 4 weeks prior to entry, or if they will need either of these during the study period. * have lost or gained a significant amount of weight (greater than 5%) within the past 2 months. * have a serious medical condition, such as heart disease. * are allergic to any of the study drugs. * have been treated for an infection or other medical illness within 14 days prior to study entry. * have had a fever (over 38.5 degrees celsius) for any 7 days or chronic diarrhea (more than 3 liquid stools per day for 15 days) within 30 days prior to study entry. * have an aids-related cancer (other than kaposi's sarcoma). * abuse alcohol or drugs. * have received certain medications. * are pregnant.

Keywords: drug therapy, combination hiv protease inhibitors lamivudine carbohydrates vx 478 reverse transcriptase inhibitors anti-hiv agents lipids insulin resistance abacavir
long-term extension study to evaluate the safety of dutogliptin/phx1149t in subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to demonstrate that dutogliptin/phx1149t is safe and tolerable.


Eligibility criteria:
inclusion criteria: * completed visit 7/day 98 of the core protocol phx1149-prot202 * current treatment of type 2 diabetes mellitus in accordance with product labeling with metformin, or thiazolidinedione (tzd), or metformin + tzd exclusion criteria: * inadequately controlled type 2 diabetes mellitus with need for therapy with insulin

Keywords: diabetes dpp4 inhibitor dutogliptin phx1149
healey als platform trial - regimen c cnm-au8

Conditions: Amyotrophic Lateral Sclerosis

Summary: the healey als platform trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of als. regimen c will evaluate the safety and efficacy of a single study drug, cnm-au8, in participants with als.

the healey als platform trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of als. this trial is designed as a perpetual platform trial. this means that there is a single master protocol dictating the conduct of the trial. the healey als platform trial master protocol is registered as nct04297683. once a participant enrolls into the master protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. all participants will have an equal chance of being randomized to any currently enrolling regimen. if a participant is randomized to regimen c - cnm-au8, the participant will complete a screening visit to assess additional regimen c eligibility criteria. once regimen c eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active cnm-au8 or matching placebo. regimen c will enroll by invitation, as participants may not choose to enroll in regimen c. participants must first enroll into the master protocol and be eligible to participate in the master protocol before being able to be randomly assigned to regimen c. for a list of enrolling sites, please see the healey als platform trial master protocol under nct04297683.

Eligibility criteria:
inclusion criteria: * no additional inclusion criteria beyond the inclusion criteria specified in the master protocol (nct nct04297683). exclusion criteria: * the following exclusion criterion is in addition to the exclusion criteria specified in the master protocol (nct nct04297683). 1. history of allergy to gold, gold salts, or colloidal gold preparations.

Keywords: als placebo-controlled double-blind regimen-specific appendix lou gehrig's disease cnm-au8 clene nanomedicine
the efficacy and safety study of tung's acupuncture for polycystic ovarian syndrome

Conditions: Polycystic Ovarian Syndrome

Summary: this study evaluates the efficacy and safety in improving ovarian function of polycystic ovarian syndrome in adults. half of patients will receive tung's acupuncture therapy, while the other half will receive diane-35(cpa/ee) as the control group.

both tung's acupuncture therapy and diane-35(cpa/ee) could improve the symptom of patients with polycystic ovarian syndrome, but until now there is no definite evidence to indicate acupuncture could play the same role in improving ovarian function. so we design this study to observe the change of follicular development, ovary size and sex hormone( testosterone, follitropin, luteinizing hormone) before and after the treatment, and evaluate the efficacy and safty of acupuncture.

Eligibility criteria:
inclusion criteria: 1. chinese; 2. 18-45 years old; 3. to meet the diagnostic criteria for polycystic ovary syndrome; 4. no need for pregnancy in the next six months; 5. volunteering to join this research and give informed consent prior to receiving treatment. exclusion criteria: 1. hypertensive patients with blood pressure exceed 160/100 mmhg; 2. a history of thrombosis,cerebrolvascular diseases, cancer, liver disease or liver dysfuction, hyperlipidemia, mental disorder, and severe infection; 3. having taken any pharmacological treatments affecting reproductive endocrine system; 4. having received acupuncture in the previous three months; 5. smoking more than 15 cigarettes per day; 6. having pacemakers, metal allergies or severe fear of acupuncture.

Keywords: acupuncture lh/fsh total testosterone (tt) polycystic ovarian syndrome(pcos)
simplification of complex insulin regimens with preserving good glycemic control in type 2 diabetes

Conditions: HBA1c; Body Weight; Hypoglycemia

Summary: this study examines prospectively the safety and efficacy of switching from multiple daily insulin injections (mdi) to once daily ideglira (insulin degludec and liraglutide fix ratio combination), a fixed-ratio combination of insulin degludec and liraglutide, in relatively well controlled (hba1c\<7.5%) subjects with type 2 diabetes using low total daily insulin dose (tdd).

type 2 diabetic patients suffering from severe hyperglycemia are often apply multiple daily insulin injections (mdi). if glucose toxicity resolves, the regimen may potentially be simplified, but there are no specific guidelines regarding this and a lot of patients are left on mdi. the investigators aimed to examine prospectively the safety and efficacy of switching from mdi to once daily ideglira, a fixed-ratio combination of insulin degludec and liraglutide, in relatively well controlled (hba1c\<7.5%) subjects with type 2 diabetes using low total daily insulin dose (tdd). the investigators hypothesize that in everyday clinical practice switching from low dose mdi to ideglira in patients of different ages with well-controlled (or overcontrolled) type 2 diabetes is safe, may induce weight loss and result in similar or better glycemic control.

Eligibility criteria:
inclusion criteria: * type 2 diabetic (t2d) patients \>18 years old * detectable random, non-fasting serum c-peptide levels * hba1c=\< 7.5% * treated with mdi (with stable daily doses of insulin at least for 90 days prior to baseline visit) * using relatively low total daily insulin dose (tdd), at baseline visit low tdd is defined as tdd\<70 iu/day and tdd\<0.6 iu/kg/day at the same time. exclusion criteria: * type 1 diabetes * treatment of t2d with any medication for diabetes other than insulin or metformin during 90 days before baseline visit * active cancer * anaemia (haemoglobin \<100g/l) * acute or chronic kidney disease with an estimated glomerular filtration rate \<30 ml/min/1.73 m2

Keywords: ideglira deintensification overtreatment simplification type 2 diabetes
clinical trial of measles, mumps and rubella combined vaccine, live

Conditions: Immunotoxicity; Vaccine

Summary: to evaluate the immunogenicity, lot-to-lot consistency and safety of three consecutive batches of measles, mumps and rubella combined vaccine, live.

to assess measles mumps and rubella combined vaccine, live, (mmr) lot-to-lot consistency in healthy chinese children at the age of 8-12 months, and the participants randomized to receive one injections of 0.5 ml measles, mumps and rubella combined vaccine, live at day 0.

Eligibility criteria:
inclusion criteria: provide vaccination certificate and birth certificate for healthy children aged 8-12 months; * volunteers' legal guardian informed consent, volunteered to participate and signed an informed consent form； * the volunteer's legal guardian has the ability to understand the research procedures, use the thermometer, scale and fill in the diary card as required, and can complete the clinical study in accordance with the requirements of the clinical trial protocol. exclusion criteria: * the axillary body temperature on the day of enrollment was more than 37.0 ℃; * have suffered from measles, mumps and rubella in the past or are suffering from measles, mumps and rubella; * any previous vaccination containing measles, mumps and rubella; * persons known to be allergic to any ingredient in the investigational vaccine; * any previous history of vaccine or drug allergy; * premature (delivered before the 37th week of pregnancy) and low weight (birth weight \< 2500g); * history of dystocia, asphyxia rescue and nervous system damage; * congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc; * acute disease, serious chronic disease or acute attack of chronic disease on the day of vaccination; * have a history of live attenuated vaccine within 28 days before vaccination and other vaccines within 7 days; * those who receive immune enhancement or inhibitor treatment within 3 months (continuous oral or drip for more than 14 days); * suffering from congenital or acquired immunodeficiency, hiv infection, lymphoma, leukemia or other autoimmune diseases; * history of asthma, unstable in the past two years, requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids; * have received blood or blood related products; * patients with progressive nervous system diseases have a history of convulsion, epilepsy, encephalopathy, guillainbarre syndrome, mental history or family history; * have a history of abnormal coagulation function (such as coagulation factor deficiency and coagulation diseases); * plan to move out before the end of the study or leave for a long time during the scheduled study visit; * participating in or planning to participate in other clinical trials in the near future; * the investigator judges any situation that is not suitable to participate in this clinical trial.

Keywords: mmr combined vaccines safety immunogenicity
development and evaluation of ai program for predicting bacterial species from urine gram stain specimens

Conditions: Bacterial Infections

Summary: the purpose of this research is to develop an ai that estimates bacterial species from gram staining images of urine specimens, and to evaluate the accuracy and labor reduction effect of gram staining automation system equipped with this ai.


Eligibility criteria:
inclusion criteria: * specimens for which urine culture and urine gram staining tests were performed for clinical purposes exclusion criteria: * samples for which suspension of use has been requested