Kornimate/medical-research-clean huggingface dataset:
measuring sensitivity to nonignorability

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to develop a new statistical index that measures sensitivity to non-ignorability (index of sensitivity to nonignorability, or isni) for model-based inferences.

background: despite a considerable number of recent developments, missing data and associated methodology continues to be an important topic of research in biostatistics, medicine and public health. as investigators begin to understand the limitations of model-based inferences under the assumption of non-ignorable missingness, recent attention has turned to the formulation and implementation of sensitivity analyses. having a general-purpose index to assess sensitivity to departures from ignorability would be extremely useful to researchers in a variety of fields in the health sciences. this is especially true if the index is relatively easy to compute and interpret. design narrative: it would be useful to have a general, easily computed diagnostic that characterizes data sets with respect to their potential for sensitivity to nonignorability. the investigators have developed a diagnostic that measures the effect of small perturbations from ignorability on coefficient estimates in the univariate linear model with missing observations.they will extend their analysis in a number of directions: i) they will develop a general class of diagnostics for bayes and direct- likelihood inferences, and demonstrate its application to a number of important special cases. ii) they will develop an analogous theory for sensitivity to nonignorability in frequentist estimation and testing. iii) they will develop a general form of the diagnostic for the coarse-date model, a generalization of missing data that includes censoring and rounding as special cases. iv) they will analyze a number of real- world data sets that represent important cases where nonignorability is of interest, including dropout in longitudinal data, censored survival data, and cross-over in clinical trials.

Eligibility criteria:
no eligibility criteria
perineural dexamethasone in femural nerve block after ligament reconstruction

Conditions: Postoperative Pain

Summary: the effect of perineural dexamethasone administered as an adjuvant in prolonging the duration of analgesia continues to be under debate. the investigators performed a prospective randomized study to evaluate the effect of perineural dexamethasone in different concentrations in postoperative analgesia in femoral nerve block for anterior cruciate ligament reconstruction.

after ethics committee approval, 75 patients american society of anesthesiologists score (asa) i-iii were randomized at the end of surgery into 3 groups of 25 patients each who underwent femoral nerve block: group a with 20 ml ropivacaine 0,5% and 20 ml lidocaine 1%; group b with 20 ml ropivacaine 0,5%, 20 ml lidocaine 1% and 4 mg dexamethasone; group c with 20 ml ropivacaine 0,5%, 20 ml lidocaine 1% and 8 mg dexamethasone. all groups received postoperative analgesia when visual analog scale (vas) over 3 (by request), with iv perfalgan 1 g and morphine (loading dose 0.1 mg/kg and titration until vas under 3, followed by subcutaneous (sc) administration of 1/2 of total loading dose on demand for the following 24 hours (h) . efficacy was evaluated by the time interval from performing the block until the first analgesic dose required, the total amount of morphine in the first 24 h postoperative, the patient satisfaction and the neurological side effects.

Eligibility criteria:
inclusion criteria: * asa i-iii * bmi\<40 exclusion criteria: * high risk grade hypertension * chronic renal failure * known allergy to drugs used * chronic treatment with steroids * drugs dependency * history of diabetes mellitus * ulcer or chronic gastritis * infection on the puncture site * neuropathy at the surgical level * coagulopathy * requesting another type of anesthesia * fear to sign informed consent * by-pass aorto-femoral
survival outcomes of ovarian malignancies in chinese population

Conditions: Ovarian Neoplasms; Survival

Summary: this study aims to determine survival outcomes (overall survival and progression-free survival) of primary ovarian malignancies in china and relevant risk factors in a prospective cohort study.


Eligibility criteria:
inclusion criteria: * primary ovarian malignancies. exclusion criteria: * metastatic malignancies to ovaries.
therapeutic rest to delay admission in early labor: a prospective study on morphine sleep

Conditions: Labor Pain; Early Labor

Summary: this will be a prospective study on labor characteristics, and obstetric and neonatal outcomes in women who accept and women who decline morphine as a form of pain management in labor. the study will also investigate patient satisfaction with this form of analgesia. the participants will be those who accept morphine and promethazine and those who decline morphine and promethazine for pain control.

objective: therapeutic rest in labor involves administration of parenteral analgesics in early or prodromal labor to relieve the patient's discomfort and allow for progression of labor while the patient rests. no prospective studies exist which examine the safety and clinical utility of therapeutic rest in early labor, and no published studies examine the potential benefits of therapeutic rest from the perspective of either patient satisfaction or cost-effectiveness. the investigators aim to determine whether therapeutic rest using morphine and promethazine is associated with variations in labor characteristics, or obstetric or neonatal outcomes as well as patient satisfaction with this form of pain management. methods: this will be a prospective cohort study. women who are eligible for therapeutic rest (reactive non-stress test, normal amniotic fluid, in prodromal or early labor as defined by obstetric provider, and plan to discharge home after evaluation) will be recruited for the study. participants will receive routine obstetric care by providers who are unaware of patient enrollment. a research assistant will then approach all participants in the postpartum period, prior to discharge from the hospital or with a phone call if permitted by the patient, to complete a questionnaire including patient satisfaction items. chart review will be performed to determine differences in hospital stay and common obstetric and neonatal outcomes to compare these data among women who do and do not choose to receive therapeutic rest. these results will provide insight into a common clinical practice, helping to not only guide management at institutions where therapeutic rest is commonly utilized but also potentially encourage its initiation at hospitals were therapeutic rest is not available.

Eligibility criteria:
inclusion criteria: * singleton pregnancies between 37w0d and 41w6d gestation * presentation to triage for rule out labor as primary indication and found to be in early labor * offered therapeutic rest by obstetric provider with plan to discharge home after evaluation exclusion criteria: * allergy to morphine sulfate or promethazine * being without an attendant to safely transport the patient home * present to triage for other indication (decreased fetal-movement, premature rupture of membranes, hypertension, etc.) * multiple gestation * known fetal anomaly * placenta previa, active maternal herpes simplex virus disease, or any other contraindication to vaginal delivery * recommendation for direct admission to l\&d for maternal or fetal indication.
weight loss effects on heart and blood vessel function in obesity

Conditions: Obesity

Summary: obesity is a growing epidemic and is associated with an increased risk of heart attack and stroke. the investigators know that obesity leads to abnormalities in how the blood vessels and the heart function and that these abnormalities are an important cause of this increased risk in obese individuals. while improvements in these abnormalities have been reported with marked weight reduction (eg surgery) and lifestyle changes including exercise training, it is not clear that these abnormalities can be substantially reversed with standard dietary interventions. additional information is needed regarding the degree of weight loss required, the time course of these improvements, nor the mechanisms. all of these have major implications for the potential role of weight loss in the management of these patients. the investigators will assess the effects of dietary induced weight loss in both the short and long term on the function of blood vessels and the heart, and the relationship of any changes with markers of inflammation that are present in obesity. by understanding the factors that are important in reversing these abnormalities in obesity the investigators will be better to identify and reduce heart attack and stroke in obese individuals in the future.


Eligibility criteria:
inclusion criteria: * obese caucasian men age 18-65 years, who are non smokers, and consuming 2 or fewer standard alcoholic drinks per day (on average over the past 5 years) will be recruited. * obesity, for the purposes of this study, is defined by a bmi \> 30 and a waist circumference \> 102 cm. * caucasian men only are enrolled because the cut-off points for the definition of obesity vary significantly by race. exclusion criteria: * men are excluded if they have any previously diagnoses or symptomatic atherosclerotic disease, or are taking any cardiovascular medication. * men with known gallstones, history of gout, or any contraindication to mri are also excluded.
the role of a device to evaluate the neuromuscular function in assessing muscle in facial paralysis patients

Conditions: Facial Nerve Palsy

Summary: the objective of the research is to determine whether the myotonpro has a valid and reliable application in facial, head and neck surgery. in addition, the study aims to compare this new technology with current electromyography.

facial paralysis has significant aesthetic, functional and psycho-social morbidity. the diagnosis and monitoring of neuromuscular recovery is limited to clinical examination, electromyography (emg) and electroneurography (enog). emg and enog is invasive for the patient and has practical and cost disadvantages. the myotonpro is a handheld device, which is pain-free and quick to use. therefore this research is assessing myotonpro technology for this clinical application and may be effective at evaluating rehabilitative and surgical interventions. phase 1 - variation of measurements phase 2 - mimic muscle dysfunction assessment phase 3 - peri-operative mimic and temporalis muscle assessment phase 4 - phase 3 including electromyography phase 5 - temporalis and mimic muscle assessment following facial reanimation surgery

Eligibility criteria:
inclusion criteria: 1. unilateral peripheral facial nerve palsy 2. mental capacity to give consent 3. the patient is able to sit independently exclusion criteria: 1. adults who have undertaken strenuous exercise within the last twenty-four hours 2. adults taking prescription medication with a known effect on the mechanical properties of muscle (e.g. benzodiazepines) or receiving antispasmodic medications (e.g. botulinum a toxin) 3. adults with poor mobility (unable to lie prone). 4. adults with a body mass index (bmi) \>30 kg/m2 . muscle measurements may be inaccurate with excessive subcutaneous tissue
combination therapy in patients with depression

Conditions: Depressive Symptoms

Summary: the purpose of the study is to compare sertraline and atomoxetine/sertraline combination therapy in patients with persistent depressive symptoms.


Eligibility criteria:
inclusion criteria: * meet dsm-iv criteria for major depression with a hamd-17 rating scale score of at least 18 at visit 1 * adult men or women, 18 years of age or older * must be able to swallow capsules * laboratory results must show no clinically significant abnormalities * if suicidal ideation is present, the investigator should assess its severity and the potential need for other interventions and determine whether these are compatible with study participation exclusion criteria: * have a documented history of bipolar i or ii disorder, or of psychosis. * have a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control. * have a history of adhd * have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions * are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner which the investigator considers indicative of abuse
pressurized intraperitoneal aerosol chemotherapy (pipac) using paclitaxel in gastric cancer patients with peritoneal metastasis

Conditions: Stomach Neoplasm; Peritoneal Metastases

Summary: this is a phase i trial investigating the safety of pressurized intraperitoneal aerosol chemotherapy (pipac) using paclitaxel combined with intravenous folfox therapy for gastric cancer patients with peritoneal metastasis.


Eligibility criteria:
inclusion criteria: * pathologically diagnosed as gastric adenocarcinoma * imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis * her-2 negative tumor * laboratory tests adequate for chemotherapy (within 2 weeks of enrollment) * absolute neutrophil count: ≧ 1,500/mm³ * hemoglobin level: ≧ 8.0g/dl * platelet count: ≧ 10×104/mm³ * ast (got), alt (gpt): ≦ 100u/l * total bilirubin: ≦ 2.0mg/dl * creatinine clearance (ccl): ≧ 50ml/min * ecog 0 - 2 exclusion criteria: * patients with other major medical disease or malignant tumors other than gastric cancer * contraindication to 5-fu, oxaliplatin, leukovorin or paclitaxel * pregnant, breast-feeding women or with birth plan * history of gastrointestinal surgery * patients refusing treatment
preoperative analgesia in non-gynecological cancerous women who underwent elective total abdominal hysterectomy

Conditions: Total Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , Celecoxib

Summary: comparison of effectiveness of preoperative gabapentin with celecoxib in reducing acute postoperative pain in abdominal hysterectomy, a randomized double blind controlled trial

total abdominal hysterectomy (tah) is the most common gynecological operation worldwide.some studies noticed about overused of opioids in postoperative care , leaded to more adverse effect of opioids , slowly recovery , prolong length of hospitalized stay and consequently increase unnecessary cost of treatment. eras guidelines has considered to use preoperative analgesics for reducing post-operative opioids consumption, including gabapentin and celecoxib. gabapentin and celecoxib widely used for treatment of pain and many studies have demonstrated the preoperative efficacy and safety of gabapentin and celecoxib in variety procedures involving hysterectomy.however, no definite conclusion of optimal dose and timing for preopearive uptake ,apart from no good evidences based supported preoperative gabapentin or celecoxib in hysterectomy in thailand . in addition, the protocol for preoperative analgesics in hysterectomy, has not been performed in the investigator's center. therefore the aim of this study is to assess and compare the efficacy and safety of preoperative gabapentin and celecoxib to reduce acute postoperative pain in non-gynecological cancerous woman undergoing total abdominal hysterectomy

Eligibility criteria:
inclusion criteria: * women ranging age between 18-65 years and having non-gynecological cancerous women who undergoing elective total abdominal hysterectomy * women who has asa physical status i-ii * women who agrees to participate in this study exclusion criteria: * women who pregnancy * women who have abnormal kidney function test (cr \> 1.5 ) * women who have abnormal liver function test * women with history or present of thrombosis such as myocardial infarction, ischemic stroke, deep venous thrombosis or pulmonic embolism * women with history of gastrointestinal bleeding -women with history of gastrointestinal bleeding -women with history of gastrointestinal bleeding * women who take the antiplatelet or anticoagulant medications * women with history of allergy to gabapentin ,celecoxib and sulfa * women who have used or known gabapentin or celecoxib before * women who have chronic alcoholism * women who underwent previous surgery * women who undergo extended low midline incision * women who undergo lysis adhesion * women who undergo further operations except salpingo-oophorectomy * women who cannot evaluated pain score
impact of ga-68 dotatoc pet-ct imaging in management of neuroendocrine tumors

Conditions: Neuroendocrine Tumors; Carcinoid Tumors; Neuroblastoma; Medulloblastoma

Summary: participants in this study have been diagnosed with a tumor such as a carcinoid, neuroendocrine tumor, neuroblastoma, ewing's sarcoma, or brain tumor that has cells which carry somatostatin receptors. the purpose of this research study is to see if the tumor can be identified using a special procedure called a positron emission tomography (pet) scan and how the results of this imaging procedure will change the management of the tumor.

this is a prospective, phase ii, single center, open-label study in a total of 200 participants with histologically proven neuroendocrine tumor or other somatostatin receptor positive tumors. eligible participants will undergo baseline assessments at enrollment. they will receive 68ga-dotatoc and undergo a pet/ct imaging study. participants may receive a second 68ga-dotatoc pet/ct for restaging after therapy 12-36 months following the first scan.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. age ≥ 6 months 3. histologically diagnosed neuroendocrine tumor or other tumor with probable somatostatin receptors subtype 2 4. karnofsky performance status or lansky play scale status of ≥ 60 (or ecog/who equivalent) 5. subject is male; or is a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (\> 1 years without menses), ≥60 years old,or of childbearing potential for whom a pregnancy test (with the results known prior to investigational product administration) is negative. a negative pregnancy test will be required for all female subjects with child bearing potential. if a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is not capable of becoming pregnant. female must also be non-lactating. exclusion criteria: 1. subject weighs more than 450 pounds. (subjects who weigh more than 450 pounds will not be able to fit inside the imaging machines) or otherwise cannot be safely fit into the imaging system. 2. inability to lie still for the entire imaging time (due to cough, severe arthritis, etc.) 3. inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) 4. any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance. 5. peptide receptor radionuclide therapy (prrt) within 4 weeks of ga-68 dotatoc pet/ct scan. 6. treatment with sandostatin lar within 4 weeks, sq octreotide within 12 hours, or lanreotide injection within 8 weeks of ga-68 dotatoc pet/ct (+/-5%).
does the pain experienced during orthodontic treatment and bracket removal depend on the architecture of the bracket?

Conditions: Debonding; Orthodontic Brackets

Summary: the present research aimed to thoroughly investigate the impact of bracket architecture on pain perception during active treatment, debonding, and adhesive removal.

100 consecutive patients who completed treatment with one of two bracket systems (2-slot brackets with integral base or conventional twin brackets with foil mesh) were included in this prospective clinical trial. prior to the removal of brackets, participants were asked to evaluate the level of pain encountered throughout their orthodontic treatment with the fixed appliances, utilizing a 0-10 numerical rating scale, and to indicate the main cause of pain. subsequently, brackets on the right side of both dental arches were debonded using the lift-off debonding instrument (lodi), while on the left side, the bracket removal pliers (brp). the residual adhesive was removed through two methods (manual in the upper arch and rotary in the lower). the same scale was employed to assess pain levels during brackets and adhesive removal.

Eligibility criteria:
inclusion criteria: * fixed appliance in both dental arches * brackets bonded using the transbond xt adhesive system (3m unitek, st. paul, usa) following the manufacturer's instructions exclusion criteria: * periodontal disease * restorations or caries on buccal surfaces of the teeth, * consumption of analgesics within eight hours preceding the debonding appointment

Keywords: orthodontic brackets pain measurement dental debonding
empagliflozin-based quadruple combination vs insulin glarine-based combination therapy in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study evaluates the efficacy and safety of the empagliflozin as add-on thearpy compared to insulin glargine-based antidiabetic agents (oads) combination thearpy in patients with type 2 diabetes inadequately controlled on triple oads in a real clinical practice.


Eligibility criteria:
inclusion criteria: * are inadequately controlled with triple oads (metformin, sulfonylurea, dipeptidyl peptidase inhibitor) as evidenced by hba1c \>7.5% and \<12.0% exclusion criteria: * type 1 diabetes * gestional diabetes * diabetes due to secondary causes * receiving anticancer treatment * receiving glucocorticoids or immune-suppressants * have been treated with sodium glucose co-transporter 2 inhibitors for more than 7 consecutive days within 3 months before entering the study * have been treated with any type of insulin for more than 7 consecutive days within 3 months before entering the study

Keywords: type 2 diabetes sodium glucose cotransporter 2 inhibitor empagliflozin insulin glargine